Pack & Ship – Compliant Order Fulfillment

This topic is part of the SG Systems Global regulatory & operations glossary.

Updated October 2025 • Fulfillment & Trade Compliance • Warehouse, QA, Supply Chain, Customer Service, IT/OT

Pack & Ship (Compliant Order Fulfillment) is where customer promise meets regulatory reality. The goal is simple and unforgiving: pack the right items, from the right lots and markets, into the right containers with right labels and documents, and ship only when evidence says it is legal and safe. This is not a “print and pray” activity; it’s a controlled process driven by a WMS with Directed Picking, expiry logic (FEFO/FIFO), validated labeling control with on‑line verification, and event reporting via EDI and EPCIS. When QA has not posted Lot Release (with the CoA attached), the system should physically block shipping. That is compliant fulfillment.

“A label that prints without proof is a lie. In Pack & Ship, the WMS must prove identity, status, and market truth before ink hits paper.”

1) Purpose and Position in the Stack

Pack & Ship links demand to proof. Orders arrive with lines, quantities, markets, and dates; the WMS allocates inventory under FEFO/FIFO and status constraints, drives order picking, and controls packing, labeling, and ship confirmation. QA governs release (Lot Release, CoA); customer and regulator interfaces run over EDI and EPCIS. In regulated industries, Pack & Ship is also a compliance wall: if status, identity, or market attributes are wrong, the shipment does not leave—no exceptions without formal Nonconformance and approvals.

2) Preconditions: Master Data That Makes Fulfillment Work

Shipments are only as clean as their masters. Define pack instructions, carton/pallet rules, and market attributes on the item master, including GTIN, content descriptions, required inserts (e.g., IFU), and trade data like COO/COI. Map disposition rules (Pending, Quarantine, Released) and link to QA outcomes for Finished Goods Release. Lock all labels under centralized Labeling Control with versioning, and confirm that shipping documentation pulls data from those governed masters—not from user‑editable fields. If these masters drift, your shipments will drift with them.

3) Orchestration: Waves, Clusters, and Tasking

Choose picking strategies to match order mix. For small orders, cluster or batch picking reduces travel; for large wholesale orders, discrete or wave picking with zone routing is cleaner. No matter the method, enforce Directed Picking that obeys FEFO/FIFO and blocks wrong status. At staging, the system validates each tote or pallet against the order and market rules, then hands the work to packing stations with a clear, scan‑driven flow. Off‑system pick lists are a trap; the source of truth is the WMS task with scan confirmation and an audit trail.

4) Packing Station Design—Proof Before Print

Design packing so operators cannot complete a step without proof. The station should:

• Scan item, lot, and—if applicable—unit serials (Serialization) to tie content to the order.
• Enforce FEFO/FIFO by rejecting aged lots that violate rule (FEFO/FIFO).
• Pull label templates from Labeling Control and lock variable data (lot, expiry, COO/COI, GTIN) from governed masters.
• Run Label Verification (or Machine Vision) before apply.
• Aggregate contents to a carton/pallet with a validated SSCC and publish the hierarchy via EPCIS when closed.

If a pack station can print labels without a successful verification scan or status check, you are paying for speed with customer risk—and regulatory exposure. Stop that at design time.

5) Labeling and Documents—Single Source of Truth

Everything printed must be under Labeling Control with version history. Carton labels, pallet labels (SSCC), and market‑specific stickers all pull variable data from the same governed fields: item/GTIN, lot, expiry, quantity, and market attributes like COO and COI. When a CoA or IFU must accompany a shipment, the system proves attachment by order/lot; shipping cannot close without it. Labels are not free text; they are controlled outputs from validated data.

6) Serialization and Aggregation—Make Every Unit Count

Where regulation or customer programs require unit traceability, pack & ship must handle unit serial capture (Serialization) and aggregation to case/pallet with SSCC. Closing a case or pallet publishes an EPCIS event with child membership and destination (EPCIS). Returns de‑aggregate, quarantine, and—if reused—re‑commission according to governed rules. Without these steps, you cannot defend a recall or prove custody to partners.

7) QA Gating—Ship Only What’s Released

Finished goods move only on Release. The WMS must block ship confirmation until QA posts Lot Release with a valid CoA. If lots are partial or mixed, the system verifies each line’s lot set individually. Overrides are not “quick clicks”; they are controlled NCR events with approvals. Anything less is wishful thinking disguised as throughput.

8) Trade & Distribution Integrity—Market Truth in the Box

Distribution has obligations: cold chain, product defense, and lawful labeling. If you ship healthcare or food, align processes to GDP, HACCP, and Food Defense. Tie allergen‑containing items to controlled areas and materials per Allergen Segregation and High‑Risk Allergen rules. If U.S. drug labeling applies, ensure item masters align to NDC and that the label template is current. This is how you make “market truth” more than a slide in a deck.

9) Ship Confirmation and Partner Signals

Shipping closes with proof. The WMS reconciles picks to packs, packs to labels, and labels to documents. When confirmed, it emits partner signals—typically EDI shipment notices—and, if serialized or aggregated, EPCIS events carrying SSCC hierarchies. Mismatches block confirmation; exceptions open NCRs. The outcome is predictable delivery backed by defensible records—not surprise calls from customers about wrong lots or missing inserts.

10) Returns, Recalls, and Genealogy

Pack & Ship must also handle the reverse. Returns are received as controlled events tied to the original order and lot/serials; they are quarantined and assessed before restock. Recalls rely on Genealogy that spans from batch to bin to customer (Batch‑to‑Bin Traceability). If you cannot list recipients for a lot quickly and show what remains in stock, the system has failed. That list should come from scans, not from memory or inbox archaeology.

11) Data Integrity, Validation, and Change Governance

Pack & Ship creates electronic records that enable product release and legal commerce; it therefore operates under 21 CFR Part 11 and Annex 11 expectations. That means unique credentials, e‑signatures with meaning, computer‑generated audit trails, time synchronization, and secure retention. Validate flows under GAMP 5 with risk‑based CSV: prove negative paths (wrong lot/status, label mismatch, missing CoA) block shipment. Keep configurations and SOPs under Document Control and route all label or rule changes via MOC. When incidents occur, log NCRs and drive fixes through CAPA. Compliance culture is built into the UI or it doesn’t exist.

12) Metrics That Prove Control

• Order‑to‑Ship Lead Time (median and 90th percentile) by channel (lead time).
• OTIF (on time, in full) with reason codes for misses (OTIF).
• Pick & Pack Accuracy (line and lot/serial accuracy) and FEFO conformance.
• Label Verification Pass Rate, reprint/void ratio, and template drift incidents (Label Verification).
• QA Gate Effectiveness: blocked shipments due to Hold or missing CoA.
• EPCIS/EDI Match Rate (events and ASNs align with physical realities) (EPCIS, EDI).
• Inventory Accuracy at pack zones and staging (Inventory Accuracy).
• Audit‑Trail Exceptions per 1,000 orders (audit trail integrity).
• Roll these into KPIs, trend through APR and CPV, and act via CAPA.

One warning sign: shipments posted before QA release. That’s not speed; that’s a system defect masquerading as service.

13) Failure Patterns (and the Antidotes)

Shadow paperwork. Off‑system pack slips and carrier labels become the “real” record. Antidote: lock prints to WMS tasks with scan confirmation and audit trails.

Status bypass. Shipping on Pending or Quarantine lots. Antidote: hard gates tied to Hold/Release and Lot Release; exceptions open NCR.

Label drift. Local templates and hand edits. Antidote: central label control, mandatory verification, and scan‑back before ship.

FEFO violations. Old stock shipped because “it was closest.” Antidote: enforced routes and pick blocking (FEFO).

EPCIS/EDI mismatches. Partners see shipments that do not match contents. Antidote: publish events on case/pallet closure, reconcile to order before confirmation (EPCIS, EDI).

Weak governance. Admins “fix” shipments by editing data after the fact. Antidote: tighten roles, run Internal Audits, route changes via MOC, and remediate via CAPA.

14) Implementation Playbook (Forward & Frank)

• Stabilize masters. GTINs, COO/COI, expiry rules, and pack instructions under Document Control.
• Wire the gates. FEFO/FIFO enforcement, status blocks (Hold/Release), lot release checks, and label verification in the station flow.
• Centralize labels. Migrate to governed templates; test negative paths during validation (CSV).
• Aggregate & publish. Implement SSCC with EPCIS publication on closure; align partner EDI.
• Prove it before go‑live. Challenge in FAT: wrong lot, missing CoA, label mismatch, expired items, and bad serials. Ship only after negative paths are blocked.
• Trend relentlessly. OTIF, label pass rate, FEFO conformance, EPCIS/EDI match rate, and audit trail exceptions—feed to APR/CPV.

Dashboards don’t ship orders; gates do. Build the gates first, then celebrate the charts.

15) How This Fits with V5 by SG Systems Global

V5 Solution Overview. The V5 platform is designed to convert warehouse truth into compliant shipments. Configuration is versioned, evidence is attributable, and cross‑module interlocks (identity, status, signatures) are testable and reportable—ideal for audited fulfillment.

V5 WMS. The V5 WMS drives Directed Picking, FEFO/FIFO routes, pack station flows with Label Verification, aggregation to SSCC, and event publication via EPCIS and EDI. It enforces QA gates (Hold/Release, Lot Release, CoA) so pending or quarantined lots cannot ship.

V5 MES. In the V5 MES, upstream line‑clearance, kitting accuracy, and eBMR genealogy feed directly into pack eligibility; the shipment record is traceable back to production lots and signatures.

V5 QMS. The V5 QMS governs label templates under Labeling Control, converts station exceptions into NCR with routed CAPA, and keeps SOPs and configuration synchronized through MOC. Bottom line: if the shipment isn’t compliant, V5 won’t let it ship—and the record shows who tried and why it failed.

16) FAQ

Q1. What’s the minimum viable control for compliant Pack & Ship?
Enforce FEFO/FIFO, status gates (Hold/Release), governed label templates with Label Verification, and ship confirmation blocks until QA posts Lot Release and required documents (e.g., CoA) are attached.

Q2. How do we handle partial shipments without losing control?
Treat each release as its own controlled event: allocate lots, verify labels, and close cartons/pallets with their own SSCC. Publish separate EPCIS events and partner EDI notices. Do not “re‑open” closed units to add product.

Q3. Where do market attributes (COO/COI, GTIN) get validated?
At the pack station from governed masters. Labels pull GTIN, COO, and COI directly; verification scans and document checks block ship if anything is missing or mismatched.

Q4. How do serialization and SSCC work with 3PLs?
Aggregate and publish at your site using SSCC and EPCIS. Provide 3PLs with the event feed and require scan‑based confirmation on receipt and ship. The SSCC becomes the contract for what is inside.

Q5. How do we prove compliance during an inspection?
Demonstrate a live blocked shipment on a pending lot, show label verification evidence with template/version, pull the full transaction chain (picks→packs→labels→ship), and produce partner signals (EDI/EPCIS) that match the physical contents and audit trail entries.

Related Reading
• Core Execution: WMS | Order Picking | Directed Picking | Bin Location Management
• Identity & Labels: Labeling Control | Label Verification | GS1 GTIN | Serialization | SSCC
• QA & Release: Hold/Release | Lot Release | CoA | Finished Goods Release
• Traceability & Partner Signals: EPCIS | EDI | Genealogy | Batch‑to‑Bin Traceability
• Safety & Distribution: GDP | HACCP | Food Defense | Allergen Segregation
• Governance & Validation: 21 CFR Part 11 | Annex 11 | Audit Trail (GxP) | GAMP 5 | CSV | MOC | CAPA | Internal Audit
• Performance: OTIF | Order‑to‑Ship Lead Time | Inventory Accuracy | KPI